Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00110422
First received: May 9, 2005
Last updated: April 7, 2011
Last verified: June 2010
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Purpose
The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients with metabolic syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome Hypertension |
Drug: Irbesartan Drug: Hydrochlorothiazide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Change from baseline in insulin resistance(MatsudaIndex)Week16
Secondary Outcome Measures:
- Change from baseline in insulin resist-QuickiIndex Week16;Change from baseline in triglyc.,BP,hs-CRP,albumin/creatinine ratio Week16;Changes from baseline-Matsuda,QuickiIndex,BP,triglyc.,hs-CRP&albumin/creatinine ratio Week28
| Estimated Enrollment: | 400 |
| Study Start Date: | November 2005 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A1 |
Drug: Irbesartan
Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
Other Name: Avapro
|
| Active Comparator: B1 |
Drug: Hydrochlorothiazide
Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must be willing and able to provide written informed consent. Subjects must read, sign, and receive a copy of the informed consent prior to any study procedures, including withdrawal of any antihypertensive medication.
- Males and females >= 18 years of age.
- Uncontrolled hypertension defined as an average systolic blood pressure >= 140 mmHg and/or an average diastolic blood pressure >= 90 mmHg. This applies to both people not taking any blood pressure medications and people taking just one blood pressure medication.
Presenting at least 2 of the following:
- Obesity;
- High triglycerides;
- Low HDL cholesterol;
- Elevated fasting glucose.
Exclusion Criteria:
- Women of child bearing potential who are not using adequate birth control.
- Women who are pregnant or breastfeeding
- Diabetics
- Systolic blood pressure >= 180 mmHg.
- Diastolic blood pressure >= 110 mmHg.
- Stroke within past 12 months.
- Myocardial infarction and heart revascularization procedure or acute angina within past 6 months.
- Moderate to severe heart failure.
- Significant kidney or liver disease.
- Cancer in past 5 years.
- Drug or alcohol abuse.
- Gout
- Lupus
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110422
Locations
| France | |
| Local Institution | |
| Angers, France | |
| Local Institution | |
| Nantes, France | |
| Local Institution | |
| Tierce, France | |
| Germany | |
| Local Institution | |
| Hannover, Germany | |
| Local Institution | |
| Muenchen, Germany | |
| Local Institution | |
| Ornbau, Germany | |
| Local Institution | |
| Rotenburg An De Fluda, Germany | |
| Local Institution | |
| Tuebingen, Germany | |
| Local Institution | |
| Villingen-Schwenningen, Germany | |
| Italy | |
| Local Institution | |
| Ancona, Italy | |
| Local Institution | |
| Chieti Scalo, Italy | |
| Local Institution | |
| Pisa, Italy | |
| Local Institution | |
| Ravenna, Italy | |
| Local Institution | |
| Sassari, Italy | |
| Norway | |
| Local Institution | |
| Oslo, Norway | |
| Local Institution | |
| Snaroya, Norway | |
| Russian Federation | |
| Local Institution | |
| Moscow, Russian Federation | |
| Local Institution | |
| Saratov, Russian Federation | |
| Local Institution | |
| St. Petersburg, Russian Federation | |
| Local Institution | |
| Yaroslavl, Russian Federation | |
| Spain | |
| Local Institution | |
| A Coruna, Spain | |
| Local Institution | |
| Barcelona, Spain | |
| Local Institution | |
| Granada, Spain | |
| Local Institution | |
| Sevilla, Spain | |
| Local Institution | |
| Zaragoza, Spain | |
Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00110422 History of Changes |
| Other Study ID Numbers: | CV131-186 |
| Study First Received: | May 9, 2005 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Food and Drug Administration France: Ministry of Health |
Keywords provided by Bristol-Myers Squibb:
|
Metabolic Syndrome |
Additional relevant MeSH terms:
|
Hypertension Metabolic Syndrome X Vascular Diseases Cardiovascular Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Hydrochlorothiazide Irbesartan Diuretics |
Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013